COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps (COCORICO)
Primary Purpose
Adenoma Colon, Colon Polyp, Colonoscopy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
exploration in white light (WLI)
Exploration in LCI
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoma Colon
Eligibility Criteria
Inclusion Criteria:
- Patient consecutively admitted for routine colonoscopy
Exclusion Criteria:
- History of recto-colic resection
- Inadequate preparation (none under Boston score <2)
- Patient referred for resection of a known polyp
- known Inflammatory Bowel Disease (IBD) or known polyposis
Sites / Locations
- Clinique Paris-BercyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
WLI-LCI group
LCI-WLI group
Arm Description
a first exploration of the right colon will be done in white light (WLI) then a second exploration will be done in LCI
a first exploration of the right colon will be done in LCI and a second exploration will be done in white light (WLI)
Outcomes
Primary Outcome Measures
the number of missed adenomas during the first exploration of the right colon
Number of polyps diagnosed on the second exploration and not removed (because not diagnosed) during the first exploration
Secondary Outcome Measures
The factors influencing these missed polyp rates
Time of exploration (in seconds)
The factors influencing these missed polyp rates
Boston scale (0 to 9)
The characteristics of the missed polyps
Size in millimeters
The characteristics of the missed polyps
type : Adenoma polyp / Advanced neoplasia polyp / Serrated polyp / Hyperplastic polyp
Adenoma Detection Rate (ADR)
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more adenoma of the right colon
Advanced Neoplasia Detection Rate (ANDR)
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more advanced neoplasia of the right colon
Serrated Polyp Detection Rate (SPDR)
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more serrated polyp of the right colon
Full Information
NCT ID
NCT04112563
First Posted
September 29, 2019
Last Updated
March 15, 2021
Sponsor
Société Française d'Endoscopie Digestive
1. Study Identification
Unique Protocol Identification Number
NCT04112563
Brief Title
COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps
Acronym
COCORICO
Official Title
COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps: A Multi Center Prospective Randomized Tandem Colonoscopy Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Société Française d'Endoscopie Digestive
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of the number of adenomas missed by the first exploration of the right colon by LCI (linked color imaging) or by white light during a colonoscopy, according to the order of randomization.
Detailed Description
All patients consecutively admitted for routine colonoscopy will be included in this prospective randomized crossover study. After randomization, a first exploration of the right colon will be performed in linked color imaging (LCI) or white light imaging (WLI) depending of the randomization. Every polyp will be resected as soon it will be detected. After this first examination, colon will be explored a second time with a light system different from the one used for the first exploration. If a polyp will be detected during the second exploration, it will be counted as a polyp missed by the first exploration method.
A- Inclusion criteria:
Patient consecutively admitted to one of the endoscopy units for routine colonoscopy (screening, positive FIT, personal or family history of polyp or cancer, symptoms)
Patient whose age is greater than or equal to 18 years and less than 90 years
Score: ASA 1, ASA 2, ASA 3
No participation in another clinical study
Signed informed consent
Exclusion criteria:
History of recto-colic resection Inadequate preparation (none under Boston score <2) Patient referred for resection of a polyp in place, known IBD (inflammatory bowel disease) or known polyposis
B- Exclusion criteria:
History of recto-colonic resection
Inadequate preparation (none under Boston score <2)
Patient referred for resection of a known polyp
Inflammatory Bowel Disease
family polyposis
Score: ASA 4, ASA 5
Pregnant woman
Patient with coagulation abnormalities preventing polyp resection: TP <50%, Platelets <50000 / mm3, effective anticoagulation in progress, clopidogrel in progress
Patient unable to personally consent
No signed informed consent
Purposes of the study:
Compare, when exploring the number of adenomas missed by the first exploration of the right colon by LCI or by white light, according to the order of randomization.
Evaluation criteria :
Main criterion:
- Missed right colon adenomas by first exploration in LCI-WLI and WLI-LCI groups
Secondary criteria
Rate of polyps missed by the first exploration
Serrated polyp rate missed by the first exploration
Advanced adenoma rate missed by the first exploration
Comparison of ADR, SPDR, given by the first exploration technique decided by randomization
Number of patients:
The expected rate of "missed adenomas" of the colon is about 20%, based on published data. Considering as relevant an 8% reduction in this rate of "missed adenomas" of the right colon by the LCI, the expected rate for LCI is therefore 12%.
With a risk of the first species of 5% (bilateral test), a power of 80%, 329 patients per group should be included in the study. Taking into account the rate lost to follow-up of 5%, we expect a total of 700 patients.
Duration of the study:
1-2 years
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Colon, Colon Polyp, Colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
the patient will be randomized and included in one of two groups: WLI-LCI group: a first exploration of the right colon will be done in white light (WLI) then a second exploration will be done in LCI LCI-WLI group: a first exploration of the right colon will be done in LCI and a second exploration will be done in white light (WLI)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WLI-LCI group
Arm Type
Active Comparator
Arm Description
a first exploration of the right colon will be done in white light (WLI) then a second exploration will be done in LCI
Arm Title
LCI-WLI group
Arm Type
Active Comparator
Arm Description
a first exploration of the right colon will be done in LCI and a second exploration will be done in white light (WLI)
Intervention Type
Procedure
Intervention Name(s)
exploration in white light (WLI)
Intervention Description
Exploration of the right colon done in white light (WLI)
Intervention Type
Procedure
Intervention Name(s)
Exploration in LCI
Intervention Description
Exploration of the right colon in linked color imaging (LCI)
Primary Outcome Measure Information:
Title
the number of missed adenomas during the first exploration of the right colon
Description
Number of polyps diagnosed on the second exploration and not removed (because not diagnosed) during the first exploration
Time Frame
1 day
Secondary Outcome Measure Information:
Title
The factors influencing these missed polyp rates
Description
Time of exploration (in seconds)
Time Frame
1 day
Title
The factors influencing these missed polyp rates
Description
Boston scale (0 to 9)
Time Frame
1 day
Title
The characteristics of the missed polyps
Description
Size in millimeters
Time Frame
1 day
Title
The characteristics of the missed polyps
Description
type : Adenoma polyp / Advanced neoplasia polyp / Serrated polyp / Hyperplastic polyp
Time Frame
1 day
Title
Adenoma Detection Rate (ADR)
Description
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more adenoma of the right colon
Time Frame
1 day
Title
Advanced Neoplasia Detection Rate (ANDR)
Description
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more advanced neoplasia of the right colon
Time Frame
1 day
Title
Serrated Polyp Detection Rate (SPDR)
Description
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more serrated polyp of the right colon
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient consecutively admitted for routine colonoscopy
Exclusion Criteria:
History of recto-colic resection
Inadequate preparation (none under Boston score <2)
Patient referred for resection of a known polyp
known Inflammatory Bowel Disease (IBD) or known polyposis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David KARSENTI, MD
Phone
+33 1 45 48 65 65
Email
karsenti@club-internet.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maira MORENO-GARCIA
Email
maira.moreno-garcia@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David KARSENTI, MD
Organizational Affiliation
Société Française d'Endoscopie Digestive
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Paris-Bercy
City
Charenton-le-Pont
ZIP/Postal Code
94220
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David KARSENTI, MD
Phone
+33143967850
Email
karsenti@club-internet.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps
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